AYActive Study! A Physical Health Activity Intervention

NCT04601948 | Completed DMC

• 1 other identifier: 201907702
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to explore the feasibility, acceptability, and efficacy of a 6-week mobile health (mHealth) physical activity intervention among adolescent and young adult (AYA) cancer survivors being treated at the University of Iowa Hospitals and Clinics.

Conditions

Cancer

Keywords

Adolescents; Young Adults

Outcome Measures

Primary Outcomes (1)

• Number of steps taken per day

  Number of steps taken per day on each day of the intervention

  Dail steps will be measured each day of the intervention for 7 weeks

Secondary Outcomes (7)

• PROMIS Fatigue Scale

  Change in fatigue over 7 weeks

• PROMISE Pain Scale

  Change in pain over 7 weeks

• PROMIS Physical Function Scale

  Change in physical function over 7 weeks

• PROMIS Depression Scale

  Change in depression over 7 weeks

• PROMIS Anxiety Scale

  Change in anxiety over 7 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Participants will receive a Fitbit activity monitor and access to the mHealth physical activity intervention for 6 weeks. The intervention will include regular motivational messages to encourage activity, a social media thread to provide social support, and a series of fun virtual walking races.

Behavioral: mHealth Activity Intervention

Interventions

mHealth Activity Intervention BEHAVIORAL

Eligible participants will receive a Fitbit activity monitor and access to our mHealth physical activity intervention for 6 weeks. The intervention will include regular motivational messages to encourage activity, a social media thread to provide social support, and a series of fun virtual walking races.

Intervention

Eligibility Criteria

• Age: 13 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male and female cancer survivors
• Diagnosed between 13 and 39 years old
• Currently 3-24 months post-treatment (or in maintenance therapy)
• Receiving survivorship care at HCCC/UIHC
• In remission
• Physically able to walk without limitations
• Own a smartphone with a data plan that is also capable of receiving and sending texts
• Able to understand English and provide informed assent/consent

You may not qualify if:

• Physically unable to walk without limitations
• Actively receiving cancer treatment
• Does not own a smartphone with a data plan
• Visual or cognitive impairments causing inability to read, complete or sign the consent form and survey
• Participants with diagnosis of thyroid cancer (due to differences in physical, psychological, emotional, and social effects)
• Presence of a psychiatric disorder that is not managed/unstable or suicidal ideation/actuation in preceding 12 months
• Currently meeting physical activity requirements per American Cancer Society guidelines (150 or more minutes per week of moderate to vigorous physical activity)

Sponsors & Collaborators

• Lucas Carr: lead
• University of Iowa: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Lucas Carr, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: The intervention will include an activity monitor and access to the mHealth physical activity intervention for 6 weeks. The intervention will include regular motivational messages to encourage activity, a social media thread to provide social support, and a series of fun virtual walking races.

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: October 26, 2020
• Study Start: November 6, 2019
• Primary Completion: September 4, 2020
• Study Completion: September 4, 2020
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)